Bioequivalence Study of Valsatril Tablet Versus Entresto® Sacubitril/Valsartan 24/26 mg Tablet.

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.

Key facts

Study ID: NCT07746908
Run by: Center for Bioequivalence Studies and Clinical Research
People needed: 60
Starts: 2025-02-06
Expected to finish: 2025-07-18
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Healthy volunteers aged 18 to 55 years inclusive.
Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
Subjects who are healthy as determined by routine physical examination, including vital sign monitoring and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis).
Subjects should have negative urine test for drugs of abuse and alcohol breath analysis at screening and prior to each check-in.
All subjects should be free from any epidemic or contagious diseases (e.g., Malaria, Dengue, Covid-19)
Subjects agreed to sign the Informed Consent Form
Subjects agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.
Subjects agreed to discontinue Vitamin, dietary supplements and herbal products 14 days prior to the first dose of study medication.

You may not qualify if…

Inability to take oral medication
History of smoking (≤3 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological /connective tissue, musculoskeletal, metabolic/nutritional, endocrine, allergy, or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication..
Known hypersensitivity to any xenobiotic and Sacubitril/Valsartan or any of the excipients.
A prior history of angioedema due to an ACEI or ARB.
Subject received any of the investigational drug within four weeks.
Subjects with salt imbalance in the blood (especially high levels of potassium in the blood).
Donation or loss of more than 400 mL of blood within 3 months prior to the screening.
Ingestion of OTC drug, within 07 days of drug administration.
History of intake of any prescribed medicine during a period of 14 days, prior to drug administration
Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
Subject with history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Sacubitril /Valsartan to the subjects.

Where it is running

Center for Bioequivalence Studies and Clinical Research (CBSCR) , ICCBS, University of Karachi — Karachi, Sindh, Pakistan

Full record on ClinicalTrials.gov

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